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PubMed2006

Intellectual property and patent in stem cell research era.

Stem cell therapy has obtained much attention, not only for its exceptional promise for curing many chronic disorders and degenerative conditions but also for its great economic potential. Apart from expenses in research laboratories and ongoing clinical trials, intellectual properties, patent of stem cell differentiation protocols, and stem cell-derived medical products for cell and tissue therapy are of very high cost. Intellectual properties and patents are inevitably important issues for stem cell researchers. Stem cell researchers in most countries have a chance to develop affordable stem cell therapy, scientific progression, and innovations for their patients. However, for this to be done, appropriate solutions for international patent barrier must be created so that the owner of the original stem cell protocols and techniques can be acknowledge, build his reputation and reap reasonable financial benefits. International patent barriers will be a crucial step to move the whole stem cell research community forward.

Biomedical Research↗
PubMed2003

Innovations and intellectual property: the case of genomic patenting.

In an effort to balance static and dynamic efficiency in the production and use of knowledge, societies institute intellectual property policies. In the United States, the patent system is a well-established mechanism to provide inventors with time-limited protection of new technologies in exchange for disclosure of information about their inventions. Emerging biotechnology, specifically the filing of patents on gene sequences, raises serious questions about whether the patent system is appropriately weighing societal costs and benefits in its grants of intellectual property protection. Gene sequences represent a hybrid case between discrete inventions and more general pieces of information that are useful for many, potentially very different, purposes. This information content in genes makes it possible for a patent on a gene to cover a wide range of possible technological applications and, as a result, be of unknown breadth when issued. This analysis explores the potential effect of these characteristics on future innovation in biotechnology.

Biotechnology↗
PubMed2000

Intellectual property law and genetic health care.

This article provides a basic analysis of intellectual property law, the treatment of genetic information under Title 35 of the United States Code, the controversies surrounding patenting of genetic sequences and related products, and the effects that restriction of information may have on the quality of health care in the United States. In addition, this piece addresses technology transfer and historical developments in public policy that have influenced patent trends. The intended product is not a rigorous review of the scientific or legal literature, as the included cases have been cited elsewhere to accentuate the same points. However, the compact format of the material should be especially valuable for physicians and health personnel who might not have been exposed to these issues as part of their formal professional training.

Genetic Therapy↗
PubMed2003

Intellectual property rights and traditional medicine: policy dilemmas at the interface.

Traditional medicines play an important role in the provision of health care in many developing countries. Their use is also significant in developed countries, increasing their commercial value. Several 'high-profile' cases of patenting of traditional medicines, without consent from or compensation to their holders, have further focussed attention on their importance. Traditional medicine usually involves biological resources and the knowledge of local and indigenous peoples and/or healers regarding their medicinal use; thus, it is interlinked with biodiversity conservation and indigenous peoples' rights over their knowledge and resources. At this multi-faceted interface, complex ethical questions arise. This article provides an overview and discussion of key issues, dilemmas and challenges. It points to possible modifications and at ways to devise new forms of intellectual property ownership that may better suit the needs of those who seek to protect traditional medicine. Yet it also questions whether such protection, which may restrict access, is the preferred option. While intellectual property protection for traditional medicines has multiple and diverse objectives, the priorities are often not clear and the strategies which could be deployed may interfere with each other, as well as with the prioritization of objectives. This is further aggravated by differences in stakeholders' concepts on ownership of knowledge and by uncertain or paradoxical effects of some potentially useful strategies. Thus, policymakers should address the multiple, multi-layered issues and questions, and try to develop a range of solutions in order to address and balance the various objectives and interests.

Developed Countries↗
PubMed2001

Nurturing your intellectual property.

The Internet is providing an alternative way for companies to harness the potential of their intellectual property and gain a steady new revenue stream in often unexpected areas.

Equipment Design↗
PubMed1996

[Intellectual property rights in Costa Rica in the light of the Biodiversity Convention].

This report analyzes intellectual property rights and acquisition of biological samples in light of the Biological Diversity Convention, with emphasis on Costa Rica. It examines the legal framework which exists for the protection of biological resources in this country, especially evaluating the law regarding protection of biota, which was approved in 1992. This includes information regarding access to genetic resources, and regulation for the aforementioned law. It examines the Biological Diversity Convention which was signed at the Rio Summit in 1992, whose objectives and goals, above all, emphasize the subject of distribution of benefits to be derived from the utilization of biological resources.

Animals↗
PubMed1996

Intellectual property and scientific research.

This paper discusses the availability of intellectual property protection for ideas and research. The main regimes discussed are copyright, patents and confidential information, although designs may also be relevant. The law in this area depends largely upon internationally agreed standards of protection and, in recent years, the Australian legislation has been amended to take account of international conventions and as a result of the formation of the World Trade Organisation. Although the legislation is detailed and highly technical, this article attempts to give an outline of the broad conceptual bases of protection and highlight the relevant threshold criteria. On the whole, it is not possible to protect ideas alone, and only specific categories of subject matter will gain legal protection.

Journal Article↗
PubMed2006

The effects of business practices, licensing, and intellectual property on development and dissemination of the polymerase chain reaction: case study.

INTRODUCTION: Polymerase chain reaction (PCR) was a seminal genomic technology discovered, developed, and patented in an industry setting. Since the first of its core patents expired in March, 2005, we are in a position to view the entire lifespan of the patent, examining how the intellectual property rights have impacted its use in the biomedical community. Given its essential role in the world of molecular biology and its commercial success, the technology can serve as a case study for evaluating the effects of patenting biological research tools on biomedical research. CASE DESCRIPTION: Following its discovery, the technique was subjected to two years of in-house development, during which issues of inventorship and publishing/patenting strategies caused friction between members of the development team. Some have feared that this delay impeded subsequent research and may have been due to trade secrecy or the desire for obtaining lucrative intellectual property rights. However, our analysis of the history indicates that the main reasons for the delay were benign and were primarily due to difficulties in perfecting the PCR technique. Following this initial development period, the technology was made widely available, but was subject to strict licensing terms and patent protection, leading to an extensive litigation history. DISCUSSION AND EVALUATION: PCR has earned approximately $2 billion in royalties for the various rights-holders while also becoming an essential research tool. However, using citation trend analysis, we are able to see that PCR's patented status did not preclude it from being adopted in a similar manner as other non-patented genomic research tools (specifically, pBR322 cloning vector and Maxam-Gilbert sequencing). CONCLUSION: Despite the heavy patent protection and rigid licensing schemes, PCR seems to have disseminated so widely because of the practices of the corporate entities which have controlled these patents, namely through the use of business partnerships and broad corporate licensing, adaptive licensing strategies, and a "rational forbearance" from suing researchers for patent infringement. While far from definitive, our analysis seems to suggest that, at least in the case of PCR, patenting of genomic research tools need not impede their dissemination, if the technology is made available through appropriate business practices.

Journal Article↗
PubMed1994

Intellectual property considerations in the development and use of HRQL measures for clinical trial research.

As a result of the expanded use of health-related quality of life (HRQL) measures in clinical trial research, a variety of legal and ethical issues have surfaced. These issues can be put in the form of the following questions: (1) Under what circumstances should access to HRQL measures be restricted? (2) Under what circumstances is it appropriate for the developers of HRQL measures to assert their intellectual property rights to the instruments? (3) Under what circumstances is personal profit from the sale and use of HRQL measures legally and socially appropriate? Access to HRQL research is to be encouraged since this is necessary for this field to progress. However, the need for protection against misuse of ongoing work is real and may justify the assertion of intellectual property rights. HRQL measures developed entirely with public monies should remain in the public domain or be managed for the public good. Instruments developed with private funds or with a mix of public and private funds should be treated in a manner that reflects a fair balance between the rights of the private developer and those of the scientific community and the public. HRQL questionnaires are regularly being refined; such work is costly. Investigators continuing research directly related to instrument refinement might reasonably ask for compensation from those who wish to use their work.

Clinical Trials as Topic↗
PubMed2006

Biodiversity, biopiracy and benefits: what allegations of biopiracy tell us about intellectual property.

This paper examines the concept of biopiracy, which initially emerged to challenge various aspects of the regime for intellectual property rights (IPR) in living organisms, as well as related aspects pertaining to the ownership and apportioning of benefits from 'genetic resources' derived from the world's biodiversity. This paper proposes that we take the allegation of biopiracy seriously due to the impact it has as an intervention which indexes a number of different, yet interrelated, problematizations of biodiversity, biotechnology and IPR. Using the neem tree case as an example, it describes activists' use of the term as one that involves a deliberate simplification of science and IPR. Additionally, it argues that in so doing, biopiracy is positioned as a touchstone that mobilizes actors and problems, and ultimately generates 'solutions' to the very challenges it creates. The paper will also encourage a view of biopiracy claims that does not always treat them simply as claims of theft, or as a misallocation of benefits, but rather as claims that are designed to raise broader questions about the IPR system itself. It concludes by advocating that, in order to properly understand how to address biopiracy, we must be prepared to move beyond the current narrow readings to develop a more complete picture of the term's influence in challenging how, and by whom, the decisions about what is natural and what is invented come to be made.

Animals↗
PubMed2004

Intellectual property. Device trade.

Potential is growing for trusts to benefit from patented innovation through nine regional knowledge hubs. Legal protection of intellectual property is essential to ensure copyright. 'Inventions' can boost trust finances, support the local economy and spread innovation throughout the NHS.

Copyright↗
PubMed1989

Economics of intellectual property rights in the international arena.

Many issues relating to the protection of intellectual property are economic in nature. This article applies economic analysis to several of those issues that arise in an international context. The first model concerns how one nation's choice of a particular form of protection will affect the economic welfare of its trading partners. Then the economics of unilateral, bilateral, and multilateral action are compared. The final analyses cover the optimal number of members in a multilateral agreement and the choice between mutually exclusive international agreements.

Cognition↗
PubMed2005

Intellectual property and the commercialization of research and development.

Concern about the commercialization of research is rising, notably in testing new drugs. The problem involves oversimplified, polarizing assumptions about research and development (R&D) and intellectual property (IP). To address this problem this paper sets forth a more complex three phase RT&D process, involving Scientific Research (R), Technological Innovation (T), and Commercial Product Development (D) or the RT&D process. Scientific research and innovation testing involve costly intellectual work and do not produce free goods, but rather require IP regulation. RT&D processes involve an unrecognized IP shift from a common IP right in public goods like information and knowledge to private IP in products and other hard assets. The question then is, what kind of IP right: private or common? Since scientific research and innovation testing require openness about adverse findings, and wide, low cost diffusion of results, they require a common, inclusive IP right. Common IP is appropriate to both sharing knowledge goods and recovering the cost of production. Research is furthermore compatible with commercialization and support by other social interests. On the other hand it is incompatible with the exclusionary private IP rights that permit restrictive publication or total suppression of information. Private IP rather than commercialization conflicts with the openness requirements of scientific research and innovation testing. Commercial funding, however, is in principle compatible with research and testing, especially when regulated by a common IP right. This reflects a pragmatic view of the fundamental interconnections of knowledge and other social interests.

Commerce↗
PubMed2006

Intellectual property and biotechnology: the U.S. internal experience--Part I.

In the development of biotechnology in the United States, many questions were raised about the appropriateness of applying to this area a traditional robust system of intellectual property rights. Despite these hesitations, the U.S. rejected suggested modifications. This was a mistake, and there is a need to develop a modified system that promotes more of the relevant ethical values.

Biomedical Research↗
PubMedDate not supplied

Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spending.

Rising prescription drug costs present a critical policy issue for Medicaid. Generic substitution can reduce costs, but the effects are undercut by extensions of intellectual property (IP) protection, elevated generic prices, and low substitution rates. Using Medicaid prescription data for amoxicillin/clavulanate, metformin, and omeprazole, we calculated the savings that could have been realized if generic drugs had been available and fully substituted at their lowest cost when IP protection first expired (an average delay of twenty-six months). The delay in availability, elevated prices, and slow uptake of generic alternatives for these three drugs alone cost Medicaid 1.5 billion dollars in 2000-2004.

Actuarial Analysis↗
PubMed2003

The dilemma of intellectual property rights for pharmaceuticals: the tension between ensuring access of the poor to medicines and committing to international agreements.

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor to medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions.

Developing Countries↗
PubMed2005

Managing severe acute respiratory syndrome (SARS) intellectual property rights: the possible role of patent pooling.

Patent applications that incorporate the genomic sequence of the severe acute respiratory syndrome (SARS) coronavirus, have been filed by a number of organizations. This is likely to result in a fragmentation of intellectual property (IP) rights which in turn may adversely affect the development of products, such as vaccines, to combat SARS. Placing these patent rights into a patent pool to be licensed on a non-exclusive basis may circumvent these difficulties and set a key precedent for the use of this form of mechanism in other areas of health care, leading to benefits to public health.

AIDS Vaccines↗